BACAMPICILLIN

Fetal Risk Summary

Bacampicillin, a penicillin antibiotic, is converted to ampicillin during absorption from the gastrointestinal tract (see Ampicillin for use in human pregnancy).

Reproduction studies have been conducted with bacampicillin in mice and rats at doses up to 750 mg/kg (greater than 25 times the recommended human dose) (1). No evidence of impaired fertility or fetal harm was found.

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 30 newborns had been exposed to bacampicillin during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Two (6.7%) major birth defects were observed (one expected). Specific information on the defects was not available, but no anomalies were observed in six categories (cardiovascular defects, oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias). The number of exposures is too small to draw any conclusions.

Breast Feeding Summary

See Ampicillin.

Reference